atural killer cell therapy in acute myeloid leukemia patients patients

Phase 1

Recruiting

Conditions: Acute myeloid leukemia.
Acute myeloblastic leukaemia
C92.0

Registration Number: IRCT20230801058996N2

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

Patients with acute myeloid leukemia (other than M3) confirmed by peripheral blood and bone marrow morphology, and flow cytometry and molecular assessments
History of transplantation with compatible allogeneic hematopoietic stem cells
Kanofsky index above 70%
Expected survival of more than six months
Absence of other confirmed malignancies
Entering the second complete remission phase (recovery of patients after the first recurrence)
High risk-patients with negative or positive minimal residual disease

Exclusion Criteria

Patients with acute myeloid leukemia-M3
Central nervous system involvement with leukemic cells in the last 3 months

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of patients who show adverse effects during or after NK cell therapy. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: The patient's statements and the medical team's examinations during the patient's regular visits to the bone marrow transplantation clinic for follow-up.;Overall survival in patients after NK cell therapy. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients.;Response to treatment based on criteria defined by the International Multiple Myeloma Working Group. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient examination in bone marrow transplantation clinic for follow-up and based on criteria defined by the International Multiple Myeloma Working Group.

Secondary Outcome Measures